FDA Approves Augtyro for NTRK-Positive Advanced Solid Tumors
By Lori Solomon HealthDay Reporter
THURSDAY, June 20, 2024 -- The U.S. Food and Drug Administration has approved Augtyro (repotrectinib), a next-generation tyrosine kinase inhibitor (TKI), for the treatment of patients with neurotrophic tyrosine receptor kinase (NTRK)-positive locally advanced or metastatic solid tumors.
Augtyro is approved for adult and pediatric patients (aged 12 years and older) with solid tumors that have an NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
The approval was based on the TRIDENT-1, phase 1/2 trial, which included both TKI-naive and TKI-pretreated patients (40 and 48 individuals, respectively), collectively representing 15 different types of solid tumor cancer. During a median follow-up of 17.8 months, 58 percent of TKI-naive patients had a confirmed objective response rate (cORR), of whom 43 percent experienced partial responses and 15 percent had complete responses. Among the TKI-naive responding patients, 83 percent were still in response at one year, and the median duration of response (mDOR) was not yet reached. During a median follow-up of 20.1 months, 50 percent of TKI-pretreated patients had a cORR, all of whom experienced partial responses and none of whom achieved complete responses. At one year, 42 percent of TKI-pretreated responding patients were still in response at one year and the mDOR was 9.9 months. Among the participants with measurable central nervous system metastases at baseline, intracranial response was seen in two of two TKI-naive patients and in three of three TKI-pretreated patients.
"NTRK fusion-positive tumors can present challenges in the clinical setting, which is why it is important that we have additional treatment options for these patients," TRIDENT-1 global trial lead Alexander Drilon, M.D., from Memorial Sloan Kettering Cancer Center in New York City, said in a statement. "The FDA approval of repotrectinib adds an important tool to our toolbox, offering oncologists a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors for both TKI-naïve and TKI-pretreated patients."
Approval of Augtyro was granted to Bristol Myers Squibb.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted June 2024
Read this next
Survival Gains Seen With Assignment to Experimental Group in Cancer Trials
TUESDAY, April 30, 2024 -- For patients with solid tumors, assignment to an experimental group in trials of investigational drugs yields significant survival gains, according to a...
AACR: Accelerated Aging Linked to Incidence of Early-Onset Cancer
TUESDAY, April 9, 2024 -- Accelerated aging (AA) is increasing and is associated with an increased incidence of early-onset solid tumors, according to a study presented at the...
Exposure to Low-Dose Ionizing Radiation Linked to Solid Cancer Mortality
MONDAY, Aug. 21, 2023 -- Protracted exposure to low-dose ionizing radiation is associated with an increased risk for solid cancer mortality, according to a study published online...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.